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U.S. Department of Health and Human Services

Class 2 Device Recall Secura DR

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 Class 2 Recall
Secura DR
see related information
Date Posted October 21, 2010
Recall Status1 Terminated on March 15, 2012
Recall Number Z-0115-2011
Recall Event ID 55922
Premarket Approval
PMA Number
Product Classification Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
Product Medtronic Secura DR, model D224DRG, and model D234DRG not available in the U.S.. Digital Dual chamber implantable cardioverter defibrillator (DDE-DDDR). Sterilized using ethylene oxide. Medtronic, Inc., Minneapolis, MN 55432 USA. Manufactured in: Juncos, Puerto Rico, USA. The Dual chamber implantable cardioverter defibrillator (ICD) is a multiprogrammable cardiac device that monitors and regulates the patient's heart rate by providing single or dual chamber rate-responsive bradycardia pacing, ventricular tachyarrhythmia therapies, and atrial tachyarrhythmia therapies. The device automatically detects ventricular tachyarrhythmias (VT/VF) and provides treatment with defibrillation, cardioversion, and antitachycardia pacing therapies. The device also automatically detects atrial tachyarrhythmias (AT/AF) and provides treatment with cardioversion and antitachycardia pacing therapies. The device responds to bradyarrhythmias by providing bradycardia pacing therapy.
Code Information Model D224DRG, serial numbers: PUG200008H thru PUG200044H, PUG200046H thru PUG200057H, PUG200059H thru PUG200176H, PUG200178H thru PUG200290H, PUG200292H thru PUG200301H, PUG200303H thru PUG200451H, PUG200453H thru PUG200474H, PUG200476H thru PUG200628H, PUG200630H thru PUG200719H, PUG200721H thru PUG200791H, PUG200793H thru PUG200994H, PUG200996H thru PUG201149H, PUG201151H thru PUG201167H, PUG201169H thru PUG201171H, PUG201172H, PUG201175H, PUG201176H, PUG201177H, PUG201178H, PUG201179H, PUG201180H, PUG201181H, PUG201182H, PUG201184H, PUG201186H, PUG201187H, PUG201188H, PUG201189H, PUG201190H, PUG201191H, PUG201192H, PUG201193H, PUG201194H, PUG201195H, PUG201196H, PUG201198H thru PUG201232H, PUG201234H thru PUG201266H, PUG201268H, PUG201269H, PUG201271H thru PUG201368H, PUG201370H thru PUG201439H, PUG201441H, PUG201442H, PUG201443H, PUG201444H, PUG201445H, PUG201446H, PUG201447H, PUG201448H, PUG201450H thru PUG201583H, PUG201585H thru PUG201629H, PUG201631H thru PUG201653H, PUG201655H thru PUG201769H, PUG201771H thru PUG201800H, PUG201802H thru PUG201812H, PUG201814H thru PUG202046H, PUG202048H thru PUG202112H, PUG202114H thru PUG202147H, PUG202149H thru PUG202163H, PUG202165H thru PUG202187H, PUG202189H, PUG202190H, PUG202191H, PUG202192H, PUG202193H, PUG202194H, PUG202195H, PUG202196H, PUG202197H, PUG202200H, PUG202201H, PUG202202H, PUG202204H thru PUG202235H, PUG202237H thru PUG202289H, PUG202291H thru PUG202320H, PUG202322H, PUG202323H, PUG202324H, PUG202326H thru PUG202336H, PUG202338H thru PUG202359H, PUG202361H thru PUG202372H, PUG202374H thru PUG202459H, PUG202463H thru PUG202492H, PUG202495H thru PUG202580H, PUG202582H, PUG202583H, PUG202584H, PUG202585H, PUG202586H, PUG202588H thru PUG202775H, PUG202777H thru PUG202875H, PUG202877H thru PUG203033H, PUG203035H thru PUG203075H, PUG203077H thru PUG203232H, PUG203234H thru PUG203417H, PUG203419H thru PUG203527H, PUG203529H thru PUG203574H, PUG203576H thru PUG203729H, PUG203731H thru PUG203784H, PUG203786H thru PUG203820H, PUG203822H thru PUG203859H, PUG203861H thru PUG203877H, PUG203879H thru PUG203954H, PUG203956H thru PUG203993H, PUG203995H thru PUG204068H, PUG204069H, PUG204070H, PUG204071H, PUG204072H, PUG204074H, PUG204075H, PUG204076H, PUG204078H thru PUG204094H, PUG204096H, PUG204097H, PUG204098H, PUG204099H, PUG204100H, PUG204101H, PUG204102H, PUG204104H thru PUG204135H, PUG204136H, PUG204138H, PUG204139H, PUG204140H, PUG204142H thru PUG204153H, PUG204155H thru PUG204169H, PUG204171H thru PUG204230H, PUG204232H thru PUG204269H, PUG204271H thru PUG204401H, PUG204403H, PUG204404H, PUG204405H, PUG204406H, PUG204407H, PUG204408H, PUG204414H, PUG204415H, PUG204416H, PUG204417H, PUG204418H, PUG204419H, PUG204420H, PUG204421H, PUG204423H thru PUG204466H, PUG204469H thru PUG204498H, PUG204500H, PUG204501H, PUG204502H, PUG204503H, PUG204504H, PUG204505H, PUG204506H, PUG204507H, PUG204508H, PUG204509H, PUG204510H, PUG204511H, PUG204512H, PUG204514H thru PUG204576H, PUG204578H thru PUG204822H, PUG204824H thru PUG204911H, PUG204913H thru PUG205188H, PUG205190H, PUG205191H, PUG205192H, PUG205194H thru PUG205284H, PUG205286H thru PUG205316H, PUG205318H, PUG205319H, PUG205320H, PUG205321H, PUG205323H thru PUG205369H, PUG205371H thru PUG205406H, PUG205408H thru PUG205492H, PUG205494H thru PUG205530H, PUG205532H thru PUG205677H, PUG205679H thru PUG205703H, PUG205705H thru PUG205789H, PUG205791H thru PUG205846H, PUG205848H thru PUG205868H, PUG205870H thru PUG205882H, PUG205884H thru PUG205978H, PUG205981H, PUG205982H, PUG205983H, PUG205985H, PUG205986H, PUG205987H, PUG205988H, PUG205989H, PUG205990H, PUG205991H, PUG205992H, PUG205993H, PUG205994H, PUG205995H, PUG205996H, PUG205997H, PUG205998H, PUG205999H, PUG206000H, PUG206001H, PUG206002H, PUG206004H, PUG206005H, PUG206006H, PUG206007H, PUG206009H, PUG206010H, PUG206011H, PUG206013H thru PUG206058H, PUG206060H thru PUG206120H, PUG206122H thru PUG206252H, PUG206254H thru PUG206472H, PUG206474H, PUG206475H, PUG206476H, PUG206477H, PUG206478H, PUG206479H, PUG206481H, PUG206482H, PUG206483H, PUG206484H, PUG206485H, PUG206486H, PUG206487H, PUG206488H, PUG206489H, PUG206490H, PUG206491H, PUG206493H, PUG206494H, PUG206495H, PUG206496H, PUG206497H, PUG206498H, PUG206499H, PUG206500H, PUG206501H, PUG206502H, PUG206503H, PUG206504H, PUG206505H, PUG206506H, PUG206507H, PUG206508H, PUG206509H, PUG206511H thru PUG206555H, PUG206557H thru PUG206795H, PUG206797H thru PUG206883H, PUG206885H thru PUG206921H, PUG206923H, PUG206924H, PUG206925H, PUG206926H, PUG206927H, PUG206928H, PUG206929H, PUG206930H, PUG206931H, PUG206932H, PUG206933H, PUG206934H, PUG206935H, PUG206936H, PUG206937H, PUG206938H, PUG206939H, PUG206941H thru PUG207031H, PUG207033H thru PUG207133H, PUG207135H, PUG207136H, PUG207137H, PUG207138H, PUG207140H, PUG207142H thru PUG207201H, PUG207203H thru PUG207257H, PUG207261H, PUG207263H, PUG207264H, PUG207265H, PUG207266H, PUG207268H thru PUG207320H, PUG207322H, PUG207323H, PUG207324H, PUG207325H, PUG207326H, PUG207327H, PUG207328H, PUG207329H, PUG207330H, PUG207337H thru PUG207366H, PUG207368H, PUG207369H, PUG207370H, PUG207371H, PUG207372H, PUG207373H, PUG207374H, PUG207375H, PUG207376H, PUG207377H, PUG207378H, PUG207379H, PUG207380H, PUG207381H, PUG207383H thru PUG207514H, PUG207516H thru PUG207637H, PUG207639H thru PUG207753H, PUG207755H thru PUG207853H, PUG207855H thru PUG207922H, PUG207924H thru PUG207954H, PUG207957H, PUG207958H, PUG207959H, PUG207960H, PUG207961H, PUG207962H, PUG207963H, PUG207964H, PUG207965H, PUG207966H, PUG207967H, PUG207968H, PUG207969H, PUG207970H, PUG207971H, PUG207972H, PUG207973H, PUG207974H, PUG207976H thru PUG208032H, PUG208034H, PUG208035H, PUG208036H, PUG208037H, PUG208038H, PUG208039H, PUG208040H, PUG208041H, PUG208042H, PUG208043H, PUG208044H, PUG208045H, PUG208046H, PUG208047H, PUG208048H, PUG208049H, PUG208050H, PUG208051H, PUG208052H, PUG208053H, PUG208054H, PUG208055H, PUG208056H, PUG208057H, PUG208058H, PUG208060H, PUG208061H, PUG208062H, PUG208063H, PUG208064H, PUG208065H, PUG208067H thru PUG208340H, PUG208342H, PUG208343H, PUG208344H, PUG208345H, PUG208346H, PUG208347H, PUG208348H, PUG208349H, PUG208350H, PUG208351H, PUG208352H, PUG208353H, PUG208354H, PUG208355H, PUG208356H, PUG208357H, PUG208359H, PUG208360H, PUG208361H, PUG208362H, PUG208363H, PUG208364H, PUG208365H, PUG208366H, PUG208367H, PUG208368H, PUG208369H, PUG208370H, PUG208372H, PUG208373H, PUG208374H, PUG208375H, PUG208376H, PUG208377H, PUG208378H, PUG208379H, PUG208380H, PUG208381H, PUG208382H, PUG208383H, PUG208384H, PUG208385H, PUG208386H, PUG208387H, PUG208388H, PUG208389H, PUG208390H, PUG208391H, PUG208392H, PUG208393H, PUG208394H, PUG208395H, PUG208396H, PUG208397H, PUG208398H, PUG208400H thru PUG208456H, PUG208458H, PUG208459H, PUG208460H, PUG208461H, PUG208462H, PUG208464H, PUG208465H, PUG208466H, PUG208467H, PUG208468H, PUG208469H, PUG208470H, PUG208471H, PUG208472H, PUG208473H, PUG208474H, PUG208475H, PUG208476H, PUG208477H, PUG208478H, PUG208479H, PUG208480H, PUG208481H, PUG208482H, PUG208483H, PUG208484H, PUG208485H, PUG208486H, PUG208487H, PUG208488H, PUG208489H, PUG208490H, PUG208491H, PUG208492H, PUG208493H, PUG208494H, PUG208496H thru PUG208528H, PUG208530H thru PUG208574H, PUG208576H thru PUG208649H, PUG208651H thru PUG208687H, PUG208689H thru PUG208782H, PUG208784H thru PUG208856H, PUG208858H thru PUG208992H, PUG208994H, PUG208995H, PUG208996H, PUG208997H, PUG208998H, PUG208999H, PUG209000H, PUG209001H, PUG209002H, PUG209003H, PUG209004H, PUG209005H, PUG209006H, PUG209007H, PUG209008H, PUG209009H, PUG209010H, PUG209011H, PUG209013H, PUG209014H, PUG209015H, PUG209017H, PUG209018H, PUG209019H, PUG209020H, PUG209021H, PUG209022H, PUG209023H, PUG209024H, PUG209025H, PUG209026H, PUG209027H, PUG209028H, PUG209029H, PUG209030H, PUG209031H, PUG209032H, PUG209033H, PUG209034H, PUG209035H, PUG209036H, PUG209037H, PUG209038H, PUG209039H, PUG209041H, PUG209042H, PUG209043H, PUG209044H, PUG209045H, PUG209046H, PUG209048H, PUG209049H, PUG209050H, PUG209051H, PUG209052H, PUG209053H, PUG209054H, PUG209055H, PUG209056H, PUG209057H, PUG209058H, PUG209059H, PUG209060H, PUG209061H, PUG209062H, PUG209063H, PUG209064H, PUG209065H, PUG209066H, PUG209067H, PUG209068H, PUG209069H, PUG209070H, PUG209071H, PUG209072H, PUG209073H, PUG209074H, PUG209075H, PUG209076H, PUG209077H, PUG209078H, PUG209079H, PUG209080H, PUG209082H, PUG209083H, PUG209084H, PUG209085H, PUG209086H, PUG209087H, PUG209088H, PUG209089H, PUG209090H, PUG209091H, PUG209092H, PUG209093H, PUG209094H, PUG209095H, PUG209096H, PUG209097H, PUG209098H, PUG209099H, PUG209100H, PUG209101H, PUG209102H, PUG209103H, PUG209104H, PUG209105H, PUG209106H, PUG209108H thru PUG209155H, PUG209157H, PUG209158H, PUG209159H, PUG209161H thru PUG209177H, PUG209179H thru PUG209273H, PUG209275H, PUG209276H, PUG209278H thru PUG209300H, PUG209302H, PUG209303H, PUG209304H, PUG209305H, PUG209306H, PUG209307H, PUG209308H, PUG209309H, PUG209310H, PUG209311H, PUG209313H thru PUG209394H, PUG209396H thru PUG209537H, PUG209539H thru PUG209746H, PUG209748H, PUG209749H, PUG209750H, PUG209751H, PUG209752H, PUG209753H, PUG209754H, PUG209755H, PUG209756H, PUG209758H thru PUG209811H, PUG209813Hthru PUG209988H, PUG209990H, PUG209991H, PUG209992H, PUG209993H, PUG209994H, PUG209995H, PUG209996H, PUG209997H, PUG209998H, PUG209999H, PUG210000H, PUG210001H, PUG210002H, PUG210003H, PUG210004H, PUG210005H, PUG210006H, PUG210007H, PUG210008H, PUG210009H, PUG210010H, PUG210011H, PUG210013H, PUG210014H, PUG210015H, PUG210016H, PUG210017H, PUG210018H, PUG210019H, PUG210020H, PUG210021H, PUG210022H, PUG210023H, PUG210024H, PUG210025H, PUG210026H, PUG210027H, PUG210028H, PUG210029H, PUG210030H, PUG210031H, PUG210032H, PUG210036H thru PUG210097H, PUG210099H, PUG210100H, PUG210101H, PUG210102H, PUG210103H, PUG210104H, PUG210105H, PUG210106H, PUG210107H, PUG210109H thru PUG210142H, PUG210144H, PUG210145H, PUG210146H, PUG210147H, PUG210148H, PUG210149H, PUG210150H, PUG210151H, PUG210152H, PUG210153H, PUG210154H, PUG210155H, PUG210157H, PUG210158H, PUG210160H thru PUG210193H, PUG210195H thru PUG210369H, PUG210371H thru PUG210400H, PUG210402H thru PUG210500H, PUG210502H, PUG210503H, PUG210504H, PUG210505H, PUG210506H, PUG210507H, PUG210508H, PUG210510H thru PUG210549H, PUG210551H thru PUG210594H, PUG210596H thru PUG210609H, PUG210611H thru PUG210636H, PUG210638H thru PUG210746H, PUG210748H thru PUG211058H, PUG211060H thru PUG211121H, PUG211123H thru PUG211202H, PUG211204H thru PUG211298H, PUG211300H thru PUG211360H, PUG211362H, PUG211363H, PUG211364H, PUG211365H, PUG211366H, PUG211367H, PUG211368H, PUG211369H, PUG211370H, PUG211371H, PUG211372H, PUG211373H, PUG211374H, PUG211375H, PUG211376H, PUG211378H, PUG211379H, PUG211380H, PUG211381H, PUG211382H, PUG211383H, PUG211384H, PUG211385H, PUG211386H, PUG211387H, PUG211388H, PUG211389H, PUG211390H, PUG211391H, PUG211392H, PUG211393H, PUG211394H, PUG211395H, PUG211396H, PUG211397H, PUG211398H, PUG211399H, PUG211400H, PUG211401H, PUG211403H thru PUG211469H, PUG211471H thru PUG211505H, PUG211507H thru PUG211578H, PUG211580H thru PUG211683H, PUG211708H, PUG211709H, PUG211711H, PUG211712H, PUG211713H, PUG211717H, PUG211718H, PUG211720H, PUG211721H, PUG211726H, PUG211727H, PUG211728H, PUG211729H, PUG211734H, PUG211735H, PUG211736H, PUG211738H, PUG211739H, PUG211740H, PUG211741H, PUG211742H, PUG211743H, PUG211744H, PUG211745H, PUG211746H, PUG211747H, PUG211748H, PUG211749H, PUG211750H, PUG211751H, PUG211770H thru PUG211890H, PUG211892H thru PUG211909H, PUG211911H thru PUG211975H, PUG211977H, PUG211978H, PUG211979H, PUG211980H, PUG211981H, PUG211982H, PUG211983H, PUG211984H, PUG211985H, PUG211986H, PUG211988H, PUG211989H, PUG211990H, PUG211991H, PUG211992H, PUG211993H, PUG211994H, PUG211995H, PUG211996H, PUG211997H, PUG211998H, PUG211999H, PUG212000H, PUG212001H, PUG212002H, PUG212003H, PUG212004H, PUG212005H, PUG212006H, PUG212008H thru PUG212092H, PUG212094H, PUG212095H, PUG212096H, PUG212097H, PUG212098H, PUG212099H, PUG212100H, PUG212101H, PUG212103H, PUG212104H, PUG212106H thru PUG212150H, PUG212152H thru PUG212254H, PUG212256H thru PUG212517H, PUG212519H thru PUG212670H, PUG212672H thru PUG212803H, PUG212805H thru PUG212895H, PUG212897H thru PUG212926H, PUG212928H thru PUG213017H, PUG213019H thru PUG213060H, PUG213062H thru PUG213078H, PUG213080H thru PUG213307H, PUG213309H, PUG213310H, PUG213311H, PUG213313H thru PUG213455H, PUG213457H, PUG213458H, PUG213460H thru PUG213477H, PUG213480H, PUG213481H, PUG213482H, PUG213483H, PUG213484H, PUG213485H, PUG213486H, PUG213487H, PUG213488H, PUG213489H, PUG213491H thru PUG213560H, PUG213562H thru PUG213589H, PUG213591H thru PUG213616H, PUG213618H thru PUG213648H, PUG213650H thru PUG213675H, PUG213677H thru PUG213705H, PUG213707H thru PUG213756H, PUG213758H thru PUG213776H, PUG213778H thru PUG213833H, PUG213835H thru PUG214104H, PUG214106H thru PUG214133H, PUG214135H thru PUG214385H, PUG214387H thru PUG214438H, PUG214440H, PUG214441H, PUG214442H, PUG214443H, PUG214444H, PUG214445H, PUG214446H, PUG214447H, PUG214448H, PUG214450H thru PUG214654H, PUG214657H thru PUG214741H, PUG214743H thru PUG214778H, PUG214780H thru PUG214801H, PUG214803H, PUG214804H, PUG214805H, PUG214806H, PUG214807H, PUG214808H, PUG214809H, PUG214810H, PUG214811H, PUG214812H, PUG214814H thru PUG214873H, PUG214875H thru PUG215061H, PUG215063H, PUG215064H, PUG215065H, PUG215066H, PUG215068H thru PUG215085H, PUG215087H thru PUG215141H, PUG215143H thru PUG215167H, PUG215169H, PUG215171H thru PUG215192H, PUG215194H thru PUG215220H, PUG215222H, PUG215224H, PUG215225H, PUG215226H, PUG215227H, PUG215228H, PUG215229H, PUG215231H, PUG215232H, PUG215234H, PUG215235H, PUG215236H, PUG215238H, PUG215239H, PUG215240H, PUG215241H, PUG215242H, PUG215243H, PUG215244H, PUG215245H, PUG215246H, PUG215247H, PUG215248H, PUG215249H, PUG215250H, PUG215251H, PUG215252H, PUG215253H, PUG215255H thru PUG215307H, PUG215309H thru PUG215322H, PUG215325H thru PUG215345H, PUG215348H thru PUG215564H, PUG215566H thru PUG215618H, PUG215620H thru PUG215981H, PUG215983H, PUG215984H, PUG215985H, PUG215987H thru PUG216083H, PUG216085H thru PUG216098H, PUG216100H, PUG216101H, PUG216102H, PUG216103H, PUG216104H, PUG216105H, PUG216106H, PUG216107H, PUG216108H, PUG216109H, PUG216110H, PUG216111H, PUG216112H, PUG216113H, PUG216114H, PUG216115H, PUG216116H, PUG216117H, PUG216118H, PUG216119H, PUG216120H, PUG216121H, PUG216122H, PUG216123H, PUG216124H, PUG216125H, PUG216126H, PUG216127H, thru PUG216128H, PUG216130H thru PUG216200H, PUG216202H thru PUG216240H, PUG216242H thru PUG216281H, PUG216283H thru PUG216324H, PUG216326H thru PUG216377H, PUG216379H thru PUG216845H, PUG216848H thru PUG216883H, PUG216885H thru PUG217124H, PUG217126H thru PUG217338H, PUG217340H thru PUG217713H, PUG217715H thru PUG218046H, PUG218048H, PUG218049H, PUG218051H thru PUG218071H, PUG218073H thru PUG218106H, PUG218108H thru PUG218205H, PUG218207H thru PUG218348H, PUG218350H thru PUG218691H, PUG218693H thru PUG218911H, PUG218913H thru PUG219010H, PUG219012H thru PUG219033H, PUG219035H thru PUG219396H, PUG219398H, PUG219400H thru PUG219459H, PUG219461H thru PUG219499H, PUG219501H thru PUG219539H, PUG219541H, PUG219542H, PUG219543H, PUG219544H, PUG219545H, PUG219546H, PUG219547H, PUG219548H, PUG219550H, PUG219552H thru PUG219579H, PUG219581H, PUG219582H, PUG219584H, PUG219585H, PUG219586H, PUG219587H, PUG219588H, PUG219589H, PUG219590H, PUG219591H, PUG219592H, PUG219593H, PUG219594H, PUG219596H, PUG219597H, PUG219598H, PUG219599H, PUG219600H, PUG219601H, PUG219603H thru PUG219628H, PUG219630H thru PUG219655H, PUG219657H thru PUG219825H, PUG219827H, PUG219828H, PUG219829H, PUG219830H, PUG219831H, PUG219832H, PUG219833H, PUG219834H, PUG219836H, PUG219837H, PUG219838H, PUG219839H, PUG219840H, PUG219841H, PUG219842H, PUG219843H, PUG219844H, PUG219845H, PUG219846H, PUG219847H, PUG219848H, PUG219849H, PUG219850H, PUG219851H, PUG219853H thru PUG219872H, PUG219875H thru PUG219914H, PUG219916H, PUG219917H, PUG219918H, PUG219919H, PUG219920H, PUG219921H, PUG219922H, PUG219923H, PUG219925H thru PUG219942H, PUG219944H thru PUG220071H, PUG220073H, PUG220074H, PUG220076H thru PUG220140H, PUG220142H thru PUG220236H, PUG220238H thru PUG220283H, PUG220285H thru PUG220306H, PUG220309H, PUG220310H, PUG220311H, PUG220312H, PUG220315H thru PUG220328H, PUG220330H, PUG220331H, PUG220332H, PUG220333H, PUG220334H, PUG220335H, PUG220336H, PUG220337H, PUG220338H, PUG220339H, PUG220340H, PUG220341H, PUG220342H, PUG220344H thru PUG220375H, PUG220377H, PUG220378H, PUG220379H, PUG220380H, PUG220381H, PUG220382H, PUG220383H, PUG220384H, PUG220386H thru PUG220445H, PUG220447H, PUG220448H, PUG220449H, PUG220450H, PUG220453H, PUG220455H, PUG220457H, PUG220458H, PUG220460H thru PUG220618H, PUG220620H, PUG220621H, PUG220622H, PUG220624H, PUG220625H, PUG220626H, PUG220627H, PUG220628H, PUG220629H, PUG220631H thru PUG220682H, PUG220684H thru PUG220768H, PUG220770H, PUG220772H thru PUG220887H, PUG220889H thru PUG221143H, PUG221145H, PUG221146H, PUG221147H, PUG221148H, PUG221149H, PUG221151H, PUG221152H, PUG221153H, PUG221154H, PUG221155H, PUG221156H, PUG221157H, PUG221158H, PUG221159H, PUG221160H, PUG221161H, PUG221163H thru PUG221212H, PUG221214H thru PUG221239H, PUG221241H thru PUG221303H, PUG221305H, PUG221306H, PUG221307H, PUG221308H, PUG221309H, PUG221310H, PUG221312H, PUG221313H, PUG221314H, PUG221315H, PUG221316H, PUG221317H, PUG221319H, PUG221320H, PUG221321H, PUG221322H, PUG221323H, PUG221324H, PUG221325H, PUG221326H, PUG221327H, PUG221328H, PUG221329H, PUG221330H, PUG221331H, PUG221333H thru PUG221365H, PUG221367H thru PUG221380H, PUG221382H thru PUG221427H, PUG221429H thru PUG221473H, PUG221475H thru PUG221670H, PUG221672H thru PUG221710H, PUG221712H thru PUG221807H, PUG221809H thru PUG221830H, PUG221832H, PUG221833H, PUG221834H, PUG221835H, PUG221837H, PUG221838H, PUG221839H, PUG221840H, PUG221842H, PUG221843H, PUG221844H, PUG221845H, PUG221846H, PUG221847H, PUG221848H, PUG221849H, PUG221850H, PUG221851H, PUG221853H, PUG221854H, PUG221856H, PUG221858H thru PUG221886H, PUG221888H thru PUG221925H, PUG221931H thru PUG221945H, PUG221947H thru PUG221971H, PUG221973H thru PUG222021H, PUG222023H, PUG222024H, PUG222026H thru PUG222040H, PUG222042H thru PUG222146H, PUG222148H thru PUG222276H, PUG222278H thru PUG222499H, PUG222501H thru PUG222576H thru PUG222646H, PUG222648H thru PUG222828H, PUG222830H, PUG222831H, PUG222832H, PUG222834H, PUG222835H, PUG222836H, PUG222837H, PUG222838H, PUG222839H, PUG222840H, PUG222841H, PUG222842H, PUG222843H, PUG222844H, PUG222845H, PUG222846H, PUG222847H, PUG222849H thru PUG222863H, PUG222865H thru PUG222896H, PUG222898H, PUG222899H, PUG222900H, PUG222901H, PUG222902H, PUG222903H, PUG222904H, PUG222905H, PUG222907H thru PUG223121H, PUG223123H thru PUG223228H, PUG223230H thru PUG223378H, PUG223380H thru PUG223445H, PUG223447H thru PUG223502H, PUG223504H thru PUG223515H, PUG223517H, PUG223518H, PUG223519H, PUG223520H, PUG223521H, PUG223522H, PUG223523H, PUG223524H, PUG223526H thru PUG223851H, PUG223853H thru PUG223884H, PUG223886H, PUG223887H, PUG223889H thru PUG223923H, PUG223925H thru PUG223942H, PUG223944H thru PUG224000H, PUG224002H thru PUG224034H, PUG224036H thru PUG224066H, PUG224068H thru PUG224150H, PUG224153H thru PUG224206H, PUG224208H thru PUG224237H, PUG224239H, PUG224240H, PUG224241H, PUG224242H, PUG224243H, PUG224244H, PUG224246H, PUG224247H, PUG224248H, PUG224249H, PUG224250H, PUG224251H, PUG224252H, PUG224253H, PUG224254H, PUG224255H, PUG224256H, PUG224258H thru PUG224366H, PUG224368H thru PUG224410H, PUG224412H thru PUG224473H, PUG224475H thru PUG224625H, PUG224627H thru PUG224685H, PUG224687H thru PUG224752H, PUG224754H thru PUG224802H, PUG224804H thru PUG224935H, PUG224937H, PUG224938H, PUG224940H, PUG224941H, PUG224943H thru PUG224987H, PUG224989H thru PUG225239H, PUG225241H thru PUG225285H, PUG225287H thru PUG225327H, PUG225329H thru PUG225360H, PUG225362H thru PUG225380H, PUG225382H thru PUG225400H, PUG225402H, PUG225403H, PUG225404H, PUG225405H, PUG225406H, PUG225407H, PUG225408H, PUG225409H, PUG225411H, PUG225412H, PUG225414H, PUG225415H, PUG225417H, PUG225418H, PUG225419H, PUG225420H, PUG225421H, PUG225422H, PUG225423H, PUG225424H, PUG225425H, PUG225426H, PUG225427H, PUG225428H, PUG225429H, PUG225430H, PUG225431H, PUG225432H, PUG225433H, PUG225435H thru PUG225470H, PUG225472H thru PUG225502H, PUG225504H thru PUG225935H, PUG225937H thru PUG225949H, PUG225951H thru PUG225995H, PUG225997H thru PUG226022H, PUG226024H thru PUG226225H, PUG226227H thru PUG226253H, PUG226255H thru PUG226763H, PUG226765H thru PUG226794H, PUG226796H thru PUG226875H, PUG226877H thru PUG226896H, PUG226898H thru PUG226966H, PUG226968H, PUG226969H, PUG226970H, PUG226971H, PUG226972H, PUG226973H, PUG226974H, PUG226975H, PUG226976H, PUG226978H thru PUG227013H, PUG227015H, PUG227016H, PUG227017H, PUG227018H, PUG227019H, PUG227020H, PUG227021H, PUG227022H, PUG227023H, PUG227024H, PUG227026H thru PUG227077H, PUG227079H, PUG227081H thru PUG227121H, PUG227123H thru PUG227134H, PUG227136H, PUG227137H, PUG227138H, PUG227139H, PUG227140H, PUG227141H, PUG227142H, PUG227143H, PUG227144H, PUG227146H thru PUG227546H, PUG227548H thru PUG227582H, PUG227584H, thru PUG227685H, PUG227686H, PUG227687H, PUG227688H, PUG227690H thru PUG227738H, PUG227740H thru PUG227782H, PUG227784H thru PUG227824H, PUG227826H thru PUG228037H, PUG228039H, PUG228040H, PUG228041H, PUG228042H, PUG228043H, PUG228044H, PUG228046H, PUG228047H, PUG228048H, PUG228049H, PUG228050H, PUG228051H, PUG228052H, PUG228053H, PUG228054H, PUG228055H, PUG228056H, PUG228057H, PUG228059H thru PUG228129H, PUG228131H thru PUG228150H, PUG228152H thru PUG228235H, PUG228238H thru PUG228281H, PUG228283H thru PUG228296H, PUG228298H thru PUG228358H, PUG228360H thru PUG228386H, PUG228391H, PUG228392H, PUG228396H thru PUG228432H, PUG228438H, PUG228439H, PUG228440H, PUG228442H thru PUG228485H, PUG228487H thru PUG228598H, PUG228600H thru PUG228713H, PUG228716H thru PUG228762H, PUG228764H thru PUG228807H, PUG228809H thru PUG228940H, PUG228942H, PUG228943H, PUG228944H, PUG228946H thru PUG228973H, PUG228976H, PUG228977H, PUG228978H, PUG228979H, PUG228980H, PUG228981H, PUG228982H, PUG228983H, PUG228984H, PUG228985H, PUG228986H, PUG228988H thru PUG229052H, PUG229054H thru PUG229099H, PUG229101H, PUG229103H thru PUG229228H, PUG229230H thru PUG229307H, PUG229309H, PUG229310H, PUG229311H, PUG229313H thru PUG229373H, PUG229375H thru, PUG229444H, PUG229447H, PUG229448H, PUG229449H, PUG229451H thru PUG229488H, PUG229490H, PUG229491H, PUG229492H, PUG600002S, PUG600003S, PUG600017S thru PUG600069S, PUG600071S thru PUG600423S, PUG600425S, PUG600427S thru PUG600664S. Model D234DRG, serial numbers: PZC200002H, PZC200003H, PZC200004H, PZC200005H, PZC200006H, PZC600074S thru PZC600084S, PZC600091S, PZC600092S, PZC600093S, PZC600131S thru PZC600146S, PZC600148S, PZC600149S, PZC600150S, PZC600151S, PZC600154S thru PZC600178S, PZC600181S thru PZC600209S, PZC600212S, PZC600213S, PZC600214S, PZC600215S, PZC600216S, PZC600217S, PZC600219S, PZC600221S, PZC600222S, PZC600224S, PZC600225S, PZC600227S, PZC600228S, PZC600229S, PZC600231S, PZC600236S, PZC600238S, PZC600239S, PZC600242S, PZC600244S, PZC600246S, PZC600251S, PZC600253S, PZC600256S, PZC600257S, PZC600259S, PZC600262S, PZC600263S, PZC600264S, PZC600267S, PZC600270S, PZC600272S, PZC600273S, PZC600274S, PZC600275S, PZC600276S, PZC600278S, PZC600280S, PZC600281S, PZC600283S, PZC600285S thru PZC600300S, PZC600302S, PZC600303S, PZC600304S, PZC600305S, PZC600308S, PZC600309S, PZC600312S, PZC600316S, PZC600318S, PZC600321S, PZC600322S, PZC600323S, PZC600325S, PZC600329S, PZC600330S, PZC600331S, PZC600332S, PZC600333S, PZC600335S, PZC600336S thru PZC600347S, PZC600349S thru PZC600361S, PZC600363S, PZC600364S, PZC600365S, PZC600366S, PZC600367S, PZC600368S, PZC600370S thru PZC600380S, PZC600383S, PZC600384S, PZC600385S, PZC600386S, PZC600388S, PZC600389S, PZC600392S, PZC600394S, PZC600396S, PZC600397S, PZC600400S, PZC600403S, PZC600409S thru PZC600440S, PZC600442S, PZC600443S, PZC600484S, PZC600486S thru PZC600508S, PZC600510S, PZC600511S, PZC600512S, PZC600513S, PZC600514S, PZC600515S, PZC600516S, PZC600517S, PZC600518S, PZC600519S, PZC600521S, PZC600522S, PZC600523S, PZC600524S, PZC600525S, PZC600526S, PZC600527S, PZC600528S, PZC600529S, PZC600530S, PZC600532S thru PZC600576S, PZC600578S, PZC600579S, PZC600580S, PZC600581S, PZC600582S, PZC600583S, PZC600584S, PZC600586S, PZC600587S, PZC600588S, PZC600589S, PZC600590S, PZC600591S, PZC600592S, PZC600593S, PZC600594S, PZC600595S, PZC600597S, PZC600598S, PZC600599S, PZC600600S, PZC600601S, PZC600602S, PZC600603S, PZC600609S, PZC600616S, PZC600624S thru PZC600718S, PZC600720S, PZC600721S, PZC600722S, PZC600723S, PZC600724S, PZC600725S, PZC600726S, PZC600727S, PZC600745S thru PZC600807S, PZC600813S thru PZC600853S, PZC600855S thru PZC601098S, PZC601100S thru PZC601137S, PZC601139S, PZC601140S, PZC601141S, PZC601143S thru PZC601352S, PZC601354S, PZC601355S, PZC601356S, PZC601357S thru PZC601522S, PZC601524S thru PZC601543S, PZC601545S thru PZC601582S, PZC601584S thru PZC601591S, PZC601593S thru PZC601648S, PZC601650S, PZC601651S, PZC601652S, PZC601653S, PZC601654S, PZC601655S, PZC601656S, PZC601657S, PZC601658S, PZC601660S thru PZC601742S, PZC601744S thru PZC601848S, PZC601851S, PZC601852S, PZC601853S, PZC601854S, PZC601856S thru PZC601880S, PZC601882S thru PZC601968S, PZC601970S thru PZC601991S, PZC601993S thru PZC602021S, PZC602023S thru PZC602038S, PZC602041S thru PZC602134S, PZC602136S thru PZC602901S, PZC602903S thru PZC603114S, PZC603116S thru PZC603362S, PZC603364S, PZC603366S thru PZC603520S, PZC603522S thru PZC603929S, PZC603931S thru PZC604022S, PZC604024S, PZC604025S, PZC604026S, PZC604027S, PZC604028S, PZC604029S, PZC604031S thru PZC604147S, PZC604149S thru PZC604189S, PZC604191S thru PZC604370S, PZC604372S thru PZC604400S, PZC604402S thru PZC604454S, PZC604456S thru PZC604514S, PZC604516S thru PZC604706S, PZC604708S thru PZC605012S, PZC605014S thru PZC605089S, PZC605091S thru PZC605264S, PZC605266S thru PZC605392S, PZC605394S thru PZC605692S, PZC605694S thru PZC605760S, PZC605764S thru PZC605934S, PZC605936S thru PZC606195S, PZC606197S thru PZC606593S, PZC606595S thru PZC606666S, PZC606668S thru PZC606823S, PZC606825S thru PZC606857S, PZC606859S, PZC606860S, PZC606861S, PZC606862S, PZC606863S, PZC606864S, PZC606865S, PZC606866S, PZC606867S, PZC606869S thru PZC606963S, PZC606965S thru PZC607028S, PZC607030S thru PZC607345S, PZC607347S thru PZC607509S, PZC607511S thru PZC607587S, PZC607589S thru PZC607688S, PZC607691S thru PZC607729S, PZC607731S thru PZC607810S, PZC607812S thru PZC607912S, PZC607914S thru PZC607953S, PZC607955S thru PZC608116S, PZC608118S thru PZC608220S, PZC608222S thru PZC608276S, PZC608278S thru PZC608551S, PZC608553S thru PZC608615S, PZC608617S, PZC608619S, PZC608621S, PZC608622S, PZC608625S, PZC608626S, PZC608627S, PZC608628S, PZC608629S, PZC608631S, PZC608632S, PZC608633S, PZC608635S, PZC608636S, PZC608637S, PZC608638S, PZC608639S, PZC608641S, PZC608642S, PZC608643S, PZC608644S, PZC608645S, PZC608646S, PZC608650S thru PZC608704S, PZC608706S thru PZC609013S, PZC609015S thru PZC609124S, PZC609126S thru PZC609359S, PZC609361S thru PZC609536S, PZC609538S thru PZC609555S, PZC609557S thru PZC609724S, PZC609727S thru PZC609742S, PZC609744S thru PZC609899S, PZC609901S, PZC609903S thru PZC609925S, PZC609927S thru PZC610094S, PZC610096S thru PZC610204S, PZC610207S thru PZC610629S, PZC610631S thru PZC610727S, PZC610729S thru PZC610745S, PZC610747S thru PZC610835S, PZC610837S thru PZC611210S, PZC611212S thru PZC611227S, PZC611229S thru PZC611354S, PZC611356S thru PZC611669S, PZC611671S thru PZC611730S, PZC611732S thru PZC611892S, PZC611894S thru PZC611986S, PZC611988S, PZC611990S thru PZC612181S, PZC612183S thru PZC612202S, PZC612204S thru PZC612229S, PZC612231S thru PZC612259S, PZC612261S thru PZC612330S, PZC612332S thru PZC612356S, PZC612358S thru PZC612419S, PZC612421S thru PZC612482S, PZC612484S, PZC612485S, PZC612486S, PZC612487S, PZC612488S, PZC612490S thru PZC612540S, PZC612542S thru PZC612664S, PZC612666S thru PZC612688S, PZC612798S,
Recalling Firm/
Medtronic Inc. Cardiac Rhythm Disease Managment
8200 Coral Sea St. N.E.
Saint Paul, Minnesota 55112
Manufacturer Reason
for Recall
Medtronic is informing you of a rare device software issue in certain ICD and CRT-D devices. A software update will be available to correct his issue. There have been 5 reports of this issue occurring with no reported patient injuries or deaths. Medtronic has identified the root cause to be a rare and specific sequence of events that must occur within a few milliseconds of each other. In the u
FDA Determined
Cause 2
DESIGN: Software Design
Action Medtronic, Inc. sent an IMPORTANT MEDICAL DEVICE CORRECTION LETTER, dated May 2010 to physicians beginning May 05, 2010. The letter informed doctors of the issue and informed them that a software update would be available to correct this issue. The software was to be installed on the programmer, with a Medtronic representatives assistance, so that on a patient's next in-clinic interrogation the device would receive the upgrade automatically and their device would be corrected. For any questions regarding this recall physicians were to contact their local Medtronic Representative or Medtronic Technical Services at 800-723-4636.
Quantity in Commerce 41848
Distribution Worldwide Distribution - USA, Puerto Rico, Virgin Islands, and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Brunei Darussalam, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saint Lucia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican City, Venezuela, and Viet Nam.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LWS and Applicant = MEDTRONIC INC.